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<eudamedExport entity="devices">
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    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Square Wax Ropes, White</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H00820</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.079Z</lastUpdated>
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  <row>
    <udiDi>D661H008221</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC U-shaped Occlusal Rim Wax, 100 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H00822</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.062Z</lastUpdated>
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  <row>
    <udiDi>D661H008251</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Bite-Wafers, Double, 24 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H00825</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.041Z</lastUpdated>
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  <row>
    <udiDi>D661H008261</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Wax Sticks, Scented, 48 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H00826</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:01.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008271</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Orthodontic Tray Wax, White, 48 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H00827</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008370</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Boxing Wax, Regular 2.25 kg</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H00837</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008380</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Boxing Wax, Extra Fine, 2.25 kg</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H00838</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H008391</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Bite-Wafers, Yellow, Soft, 50 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H00839</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H026260</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Yellow Bite Wax Form #19</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H02626</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H033651</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Bite-Wafers, Green, Hard, 50 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H03365</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>D661H040301</udiDi>
    <basicUdiDi>++D661039KU</basicUdiDi>
    <tradeName>HYGENIC Bite-Wafers, Double, 24 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltene/Whaledent Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015761</manufacturerSrn>
    <authorisedRepresentativeName>Coltène/Whaledent GmbH + Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005719</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H04030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:51:00.868Z</lastUpdated>
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    <udiDi>D998629501591</udiDi>
    <basicUdiDi>++D998WACHSDRFBLC8</basicUdiDi>
    <tradeName>S-U-WACHSDRAHT, farblos, 5,0mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SCHULER-DENTAL GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>62950159</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:52.357Z</lastUpdated>
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  <row>
    <udiDi>D998631500141</udiDi>
    <basicUdiDi>++D998PLATTENWRSTMEJ</basicUdiDi>
    <tradeName>S-U-PLATTENWACHS rosa Stand.mittel, 1,5mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SCHULER-DENTAL GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006405</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020203</emdnCode>
    <emdnDescription>OCCLUSAL WAXES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63150014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:52.329Z</lastUpdated>
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    <udiDi>E1654800220</udiDi>
    <basicUdiDi>++E165TAU1OCFX0012C</basicUdiDi>
    <tradeName>HANEL Occlusion foil 12µ 22mm 1sided red</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020299</emdnCode>
    <emdnDescription>DENTAL CONTACT INDICATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>480022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.733Z</lastUpdated>
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    <udiDi>E1654800230</udiDi>
    <basicUdiDi>++E165TAU1OCFX0012C</basicUdiDi>
    <tradeName>HANEL Occlusion foil 12µ 22mm 1sided green</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020299</emdnCode>
    <emdnDescription>DENTAL CONTACT INDICATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>480023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.709Z</lastUpdated>
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    <udiDi>E1654800310</udiDi>
    <basicUdiDi>++E165TAU1OCFX0012C</basicUdiDi>
    <tradeName>HANEL Occlusion foil 12µ 80mm 1sided black</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020299</emdnCode>
    <emdnDescription>DENTAL CONTACT INDICATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>480031</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.684Z</lastUpdated>
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    <udiDi>E1654800320</udiDi>
    <basicUdiDi>++E165TAU1OCFX0012C</basicUdiDi>
    <tradeName>HANEL Occlusion foil 12µ 80mm 1sided red</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020299</emdnCode>
    <emdnDescription>DENTAL CONTACT INDICATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>480032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.666Z</lastUpdated>
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    <udiDi>E1654800330</udiDi>
    <basicUdiDi>++E165TAU1OCFX0012C</basicUdiDi>
    <tradeName>HANEL Occlusion foil 12µ 80mm 1sided green</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020299</emdnCode>
    <emdnDescription>DENTAL CONTACT INDICATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>480033</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.647Z</lastUpdated>
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    <udiDi>E1654800410</udiDi>
    <basicUdiDi>++E165TAU1OCFX0012C</basicUdiDi>
    <tradeName>HANEL Occlusion foil 12µ 22mm 2sided black</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020299</emdnCode>
    <emdnDescription>DENTAL CONTACT INDICATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>480041</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.628Z</lastUpdated>
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    <udiDi>E1654800420</udiDi>
    <basicUdiDi>++E165TAU1OCFX0012C</basicUdiDi>
    <tradeName>HANEL Occlusion foil 12µ 22mm 2sided red</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020299</emdnCode>
    <emdnDescription>DENTAL CONTACT INDICATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>480042</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.614Z</lastUpdated>
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